MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; TESTOSTERONE ASSAY

Catalog Number	08946370190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The customer suspected a sample interference.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys testosterone g2 (testosterone ii) assay on a cobas e801 immunoassay analyzer when compared to the liquid chromatography mass spectrometry (lcms) method.The initial result was reportedly 1192 ng/dl.On (b)(6) 2023 a new sample was drawn from the patient and the result was reportedly 899 ng/dl.On (b)(6) 2023 a new sample was drawn from the patient and the result was reportedly 854 ng/dl.The provider questioned the results as they did not match the patient's history.On (b)(6) 2023 a new sample was drawn from the patient and tested with lcms method.The result was reportedly approximately 200 ng/dl.The exact result was not provided.The result tested with lcms method was deemed to be correct.
Additional Manufacturer Narrative
The calibration was last performed on 15-feb-2024 and was acceptable.Data for investigation was requested but not provided.The customer declined the service visit.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Common Device Name: TESTOSTERONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18847459
• Report Number: 1823260-2024-00671
• Device Sequence Number: 7702438
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 08946370190
• Device Lot Number: 74066301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASHWAGANDHA; BUPROPION; CYCLOBENZAPRINE; HYPERTENSION MEDICATION; LISINOPRIL; MILK THISTLE; TRAMADOL
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 75 KG